ImageGrid Radiology Viewer System™ is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.

Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Device Description

ImageGrid Radiology Viewer System™ is a client/server software application that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Radiology Viewer System™ can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The device is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images.

AI/ML Overview

The provided text is a 510(k) summary for the "ImageGrid Radiology Viewer System™", a Picture Archiving Communications System (PACS). It describes the device, its indications for use, and a general statement about testing.

However, the document does not provide specific acceptance criteria or details of a study with quantitative results, sample sizes, expert qualifications, or ground truth methods that would allow for a complete answer to the request. The "Testing" section broadly states that "The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures." This is a general statement about internal validation rather than a detailed performance study suitable for evaluating specific acceptance criteria for AI or diagnostic performance.

Based on the provided text, I cannot complete the requested information for the following reasons:

No specific acceptance criteria are listed. The document does not define measurable thresholds for performance metrics (e.g., accuracy, sensitivity, specificity, or image display quality) that the device must meet.
No detailed study is presented. There is no mention of a formal clinical or technical study with a defined methodology, test set, ground truth, or statistical analysis.
The device is a PACS viewer, not an AI diagnostic tool. The text explicitly states: "Diagnosis is not performed by the software but by Radiologists. Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis." Therefore, questions related to AI-specific performance metrics, multi-reader multi-case studies with AI assistance, or standalone AI performance are not applicable to this device as described.

Attempted Answer based on the absence of information in the provided text:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document mentions "all in-house testing criteria" and "functional requirements specified in the SRS and User Manual," but does not list specific, quantifiable acceptance criteria (e.g., display accuracy metrics, data transfer integrity, uptime).*	"The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures." "The data presented ... demonstrates that the ImageGrid Radiology Viewer System performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy."

Acceptance Criteria

Reported Device Performance

Not specified in the document. The document mentions "all in-house testing criteria" and "functional requirements specified in the SRS and User Manual," but does not list specific, quantifiable acceptance criteria (e.g., display accuracy metrics, data transfer integrity, uptime).*

"The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures." "The data presented ... demonstrates that the ImageGrid Radiology Viewer System performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy."

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The "in-house testing" implies internal data, but no details on origin (e.g., country, retrospective/prospective) are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The device is a viewer, not a diagnostic AI. The document does not describe a ground truth establishment process for diagnostic performance, as the software itself does not perform diagnosis.
Adjudication method for the test set:
- Not applicable/Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document does not mention any MRMC study. The device is a PACS viewer, not an AI to be used in conjunction with human readers in a comparative effectiveness study. The text explicitly states that diagnosis is performed by human professionals.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a PACS viewer and is not intended to provide standalone diagnostic performance or an "algorithm only" interpretation. Its function is to display images for human interpretation.
The type of ground truth used:
- Not applicable. As a PACS viewer, its primary function is display and communication, not independent diagnosis where a "ground truth" for disease presence/absence would be established for algorithm performance.
The sample size for the training set:
- Not applicable. As a software application for image viewing and communication without an AI diagnostic algorithm, there would not be a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable (no training set for an AI model).

Summary

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510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

August 21, 2009

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Vincent Cipolla Candelis, Inc. 18821 Bardeen Ave. Irvine, CA 92612, USA Tel. 949.852.1000 Fax: 949.752.7317 Email: vincent.cipolla@candelis.com

OCT - 8 2000

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	ImageGrid Radiology Viewer System™
Common Name:	Picture Archiving Communications System
Device Classification:	892.2050 System, Image Processing
Product Code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

510(k) Number:	K080333	K031311
Manufacturer:	CANDELIS, INC.	DYNAMIC IMAGING, INC.
Device Name:	IMAGEGRID	INTEGRADWEB
Decision Date	02/22/2008	06/20/2003
Product Code:	LLZ	LLZ
Device ClassificationName:	SYSTEM, IMAGEPROCESSING,RADIOLOGICAL	SYSTEM, IMAGEPROCESSING,RADIOLOGICAL
Regulation Number:	Class II - 892.2050	Class II - 892.2050
Reviewed by Third Party	Yes	No

Device Description: 21 CFR 807 92(a)(4)

Indications for Use: 21 CFR 807 92(a)(5)

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distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Moixel resolution and meets other technical specifications reviewed and accepted by FDA. Diagnosis is not performed by the software but by Radiologists. Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Technological Characteristics: 21 CFR 807 92(a)(6)

ImageGrid Radiology Viewer System™ device is a software product that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Testing

The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures. The data presented in the submission demonstrates that the ImageGrid Radiology Viewer System performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy.

Conclusion: 21 CFR 807 92(b)(1)

The 510 (k) Pre-Market Notification for ImageGrid Radiology Viewer System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. ImageGrid Radiology Viewer System™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT - 8 2009

Candelis. Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062

Re: K092949

Trade/Device Name: ImageGrid Radiology Viewer System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 22, 2009 Received: September 24, 2009

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrb/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

092949 510(k) Number (if known):

Device Name: ImageGrid Radiology Viewer System™

Indications for Use:

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use × (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norris M. Whang

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).